Skip to main content
OpenTrials
Completed

NCT Number: NCT02202109

Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida

The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women
  • Haitian, Hispanic, or African American
  • Ages 30-65 years
  • Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade

Exclusion criteria

  • Women who report having had a hysterectomy
  • Women who have a history of cervical cancer
  • Women who plan to move outside of Miami-Dade county during the next six months
  • Women who are enrolled in any other cancer prevention/outreach related study
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Treatment and study plan

CHW and Self-sampling for Cervical Cancer

Behavioral

Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.

Mailed Self Sampler

Behavioral

Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;

Primary outcomes

  1. Number of Participants Completing a Self-sampling Test

    Time frame: 2 to 6 months

    The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.

Secondary outcomes

  1. Proportion of Change in Cervical Cancer Knowledge Among Participants

    Time frame: Baseline, 6 months

    Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.

  2. Proportion of Participants With a Change in Access to Care

    Time frame: Baseline, 6 months

    Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Center for Haitian Studies
  • Health Choice Network
  • National Cancer Institute (NCI)

Registry information

Official study title

Addressing Cervical Cancer Disparity in South Florida: CBPR in Action

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2014
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.